A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

Exclusion Criteria

• •Life expectancy \<1 year
• •Target vessel size \<2 mm
• •Target thrombus is in the aorta or isolated profunda artery
• •Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
• •Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
• •LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies
• •Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed \< 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery
• •Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
• •Pregnancy
• •Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
• •Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• •Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become